ORTHOCORD

Suture, Surgical, Absorbable, Polydioxanone

DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek Inc., A Johnson And Johnson Company with the FDA for Orthocord.

Pre-market Notification Details

Device IDK123668
510k NumberK123668
Device Name:ORTHOCORD
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
ContactTatyana Korsunsky
CorrespondentTatyana Korsunsky
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-29
Decision Date2013-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886705022967 K123668 000
20886705022950 K123668 000
20886705022943 K123668 000
20886705022936 K123668 000
20886705022929 K123668 000
20886705022912 K123668 000
20886705022905 K123668 000

Trademark Results [ORTHOCORD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOCORD
ORTHOCORD
78382222 3340861 Live/Registered
Johnson & Johnson
2004-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.